Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of OCD

NCT06692114 | Recruiting

• 1 other identifier: SMHC-OCD-012
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Conditions

Obsessive-Compulsive Disorder

Keywords

deep transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD

  It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe. The primary outcome measure percent reduction of Y-BOCS scores at completion of the dTMS treatment.

  baseline,2weeks,4weeks

Secondary Outcomes (3)

• To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD

  baseline,2 weeks, 4 weeks

• Change in The Beck Depression Inventory (BDI)

  baseline,2 weeks, 4 weeks

• Change in the The Beck Anxiety Inventory (BAI)

  baseline,2 weeks, 4 weeks

Other Outcomes (2)

• Attention Network Task (ANT)

  Up to 2 weeks

• Rapid Serial Visual Presentation (RSVP)

  Up to 2 weeks

Study Arms (2)

active treatment group

EXPERIMENTAL

The resting motor threshold (RMT) of the patient was measured before the first treatment. Symptom induction was performed before each treatment to achieve moderate anxiety in patients. The magnetic stimulation intensity was 100% RMT, using the deep transcranial magnetic stimulation coil H7 for treatment, with the stimulation area being the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC). Treatment was administered twice daily for 20 minutes each time for 2 weeks.

Device: Deep Transcranial Magnetic Stimulation, DTMS active

sham group

SHAM COMPARATOR

The same RMT test as the active treatment group was accepted, and symptom induction was performed before treatment to achieve moderate anxiety. During treatment, the coil in the shame treatment group only produces sound and scalp vibration, and does not generate a real magnetic field. There is no other difference between the two coils. The frequency and number of treatments were the same as those in the active treatment group.

Device: Deep Transcranial Magnetic Stimulation, DTMS sham

Interventions

Deep Transcranial Magnetic Stimulation, DTMS active DEVICE

The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Each treatment stimulates at a frequency of 20 Hz for 2 seconds, with a sequence interval of 20 seconds. Each treatment consists of 50 sequences, for a total of 2000 pulses.

active treatment group

Deep Transcranial Magnetic Stimulation, DTMS sham DEVICE

The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Compared with active treatment, the sham stimulation coil only produced sound and scalp vibration.

sham group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 50, both genders are welcome.
• DSM-5 criteria for OCD.
• Y-BOCS total score ≥ 20 despite therapeutic-dose SRI treatment or completion of at least one full course of CBT. The treatment regimen must have been stable for at least 8 weeks prior to enrollment and remain unchanged throughout the study.
• More than 9 years of education.
• Right-handed.

You may not qualify if:

• Any additional current psychiatric comorbidity, except for obsessive- compulsive personality disorder.
• Severe obsessive symptoms prevent the completion of necessary assessments.
• Has a history of receiving ECT therapy.
• Has received rTMS or tDCS treatment within the past two months.
• Has severe physical illnesses or any physical conditions that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, among others.
• Has a past history of neurological disorders (such as epilepsy, cerebrovascular accidents, etc.) or brain injuries, or a history of brain surgery.
• Has implanted medical devices such as intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, etc.
• Serious suicide risk.
• Pregnancy or nursing of an infant.

Sponsors & Collaborators

• Zhen Wang: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zhen Wang, PhD，MD

  Study Principal Investigato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen W Wang, PhD，MD

CONTACT

+86 34773516; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vice-president

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: November 18, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)